Completely Edentulous PatientsNCT05585008
Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture
A study testing two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) in people with Completely Edentulous Patients, run by Suez Canal University at 1 site in Egypt.
Trial summary
Introduction: One major complaint frequently voiced by complete denture wearers is denture retention. Conventional denture disadvantage is heat-curing resin deformation. In addition, the pack and press technique that is still more common, residual stresses that occur at the time of packing are released when the… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Completely Edentulous Patients
- What is being tested?
- two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with good neuromuscular control and free of systemic diseases
- the edentulous ridge was covered with healthy firm and dense mucosa
- They have upper and lower edentulous healthy alveolar ridges with no remaining roots, no severe bony undercut, or local pathological lesions.
- patients had no previous dentures with a nearly equal edentulous period.
Who cannot join
- history of bad habits e.g. severe clenching.
- T.M.J disorders
- patients with xerostomia, high palatal vault, and short or hyperactive lips were excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry,Suez Canal University
Bilbeis, Sharqia Province, 46213
About this study
Official title: Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture: An In-Vivo Comparative Study
Introduction:
One major complaint frequently voiced by complete denture wearers is denture retention. Conventional denture disadvantage is heat-curing resin deformation. In addition, the pack and press technique that is still more common, residual stresses that occur at the time of packing are released when the material is removed from the flask, causing the resin to shrink, and this shrinkage is cited as a cause of poor fit of the denture base, In the field of prosthetic dentistry, the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality, the mechanical properties of printed parts, the total cost and the manufacturing time. The milling process wastes large quantities of denture base material, and more recent three-dimensional (3D) prototyping promises a more sustainable additive approach by using less denture resin. However, no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing.
Read more
Aim of the study:
Investigate the effect of two techniques of complete denture manufacturing (conventional and 3D printed) on denture retention, trueness (accuracy), and satisfaction.
Methodology:
Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups, group A for conventional dentures and group B for 3D printed dentures, retention for the two groups will be measured at 0,1 and 3 months, and patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software. The results will be tabulated and statistically analyzed using the SPSS program.
Read the detailed description
Twenty patients will be selected from the Faculty of Dentistry (Suez Canal University) outpatient clinics with the following criteria:
- Patients with good neuromuscular control and free of systemic diseases
- Well-formed ridges with firm and healthy mucosa and no bilateral anterior undercuts.
The patients will be divided equally into two groups(n=10), group (A) which will receive conventional heat cure acrylic denture, and group (B) which will receive 3D printed denture.
Methodology:
A primary impression will be taken for each patient and a special self-cured acrylic tray will be fabricated.
Zinc oxide secondary impression (caves outline, Cavex Holland)will be taken for each patient. The impression will be poured with extra hard stone and labeled master cast.
The cast will be scanned and saved in standard tessellation language (stl) format (master cats).
Jaw relation records for each patient will be taken in the conventional method. For group A: the setting up of teeth will be done in a conventional way on the articulator, and flasking of the waxed-up denture will be done. Wax elimination will be done then packing of heat cure acrylic will be done.
For group B: occlusion block will be scanned (swing scanner, DOF inc, Korea)(the scanner has an accuracy of 10 μm) after taking jaw relation record.
Virtual teeth form, size, and setting will be done on the CAD software (Exocad Dental CAD 3.0, Exocad GmbH, Germany) according to jaw relation record.
The denture base extension and thickness will be designed on CAD software. The teeth will be exported in a separate file and the denture base will be exported in a separate stl file.
The virtual denture stl files will be sent to the 3D printer software (Chitubox software, CBD-Tech, china) where slicing of the file and adjustment of layers setting will be done.
The virtual denture will be sent to the 3D printer (photon 3d printer, ANYCUBIC 3D Printing, china) to be printed (printer has Y axis resolution: 1.25um and Layer resolution: 25 ~ 100um), Teeth will be printed alone using tooth-colored resin(dental sand, Harz labs, Russia) and base will be printed alone using pink resin(dental pink, HArzz lab, Russia), then it will be ethyl alcohol washed (99% ethyl alcohol) to remove excess resin. The teeth will be placed in their places in the denture base and secured using pink resin.
Post-curing for remaining uncured resin will be done using a post-curing chamber for 30 minutes (bre-lux power unit 2,bredent, united kingdom).
Regarding the maxillary denture:
Retention will be measured clinically by using a force gauge (weihang electronic gauge,weihang industries, china) for group A and group B at 0,1 and 3 months. A force gauge will be applied by fixing the chain at the center of the polished surface of the denture. The pull end of the force gauge will be connected to the denture to measure the retention. The force gauge will pull the denture vertically downward until denture retention will be lost, and the denture will move vertically. The force at which the denture dislodges will be recorded in grams. The pull-off procedure will be repeated 10 times to obtain 10 records for each elder, and then the mean of these records will be calculated.
Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008) For group, A and group B denture base will be checked for accuracy of fit after scanning using a bench scanner with 1.3 megapixels dual camera and 10-micron accuracy (swing scanner, DOF inc, Korea) and will be compared to the virtual one planned on the master cast using metrology software (Geomagic Control X,3D systems, Canada). This will be done by the superimposition of the scanned printed or processed denture and the virtual reference denture. This will be done by selecting a point-to-point match and then the best fit function.
Color maps of the surface matching differences will be done. Areas that will be yellow to red in color will indicate impingement of the denture base with the cast. Areas that will be blue in color will indicate space between the denture base and cast. The ideal denture will show a color map that will be entirely green, giving a measurement value of 0, which will represent no processing deformation and an ideal adaptation of the denture base to the cast.
The results will be tabulated and statistically analyzed using SPSS Statistics Version 20 for Windows (SPSS, Inc., an IBM Company, USA).
- Conditions
- Completely Edentulous Patients
- Being tested
- two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))
- Keywords
- 3d printing, CAD-CAM, retention, adaptation, denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))Device
retention for the two groups will be measured at 0,1 and 3months, patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | group A will receive a conventional heat-cure acrylic denture Receives: Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) |
| group B | Active comparator | group B will receive a 3D printed complete denture Receives: Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of fit (adaptation)
the deviation of the denture fiitng surface from its corresponding cast will be measured using metrology software (GOM inspect,USA))
Measured: 1 week
retention
retention will be measured using digital force gauge(weihang electronic gauge,weihang industries, china)
Measured: 3 months
patient satisfaction
Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008)
Measured: 3 months
Secondary outcomes (1)
retention over time period
change in denture retention over time period(0,1 and 3 months from denture insertion) will be measured for each group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Aug 2021
- Primary completion1 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Completely Edentulous PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585008
- Sponsor's protocol ID
- 318/2021
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Goodacre BJ, Goodacre CJ, Baba NZ, Kattadiyil MT. Comparison of denture base adaptation between CAD-CAM and conventional fabrication techniques. J Prosthet Dent. 2016 Aug;116(2):249-56. doi: 10.1016/j.prosdent.2016.02.017. Epub 2016 Apr 23.
PubMed 27112416
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture: An In-Vivo Comparative Study
- ClinicalTrials.gov ID
- NCT05585008
- Acronym / sponsor ID
- 318/2021
- Conditions
- Completely Edentulous Patients
- Keywords
- 3d printing, CAD-CAM, retention, adaptation, denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
One major complaint frequently voiced by complete denture wearers is denture retention. Conventional denture disadvantage is heat-curing resin deformation. In addition, the pack and press technique that is still more common, residual stresses that occur at the time of packing are released when the material is removed from the flask, causing the resin to shrink, and this shrinkage is cited as a cause of poor fit of the denture base, In the field of prosthetic dentistry, the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality, the mechanical properties of printed parts, the total cost and the manufacturing time. The milling process wastes large quantities of denture base material, and more recent three-dimensional (3D) prototyping promises a more sustainable additive approach by using less denture resin. However, no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing.
Aim of the study:
Investigate the effect of two techniques of complete denture manufacturing (conventional and 3D printed) on denture retention, trueness (accuracy), and satisfaction.
Methodology:
Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups, group A for conventional dentures and group B for 3D printed dentures, retention for the two groups will be measured at 0,1 and 3 months, and patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software. The results will be tabulated and statistically analyzed using the SPSS program.
Detailed description
Twenty patients will be selected from the Faculty of Dentistry (Suez Canal University) outpatient clinics with the following criteria:
- Patients with good neuromuscular control and free of systemic diseases
- Well-formed ridges with firm and healthy mucosa and no bilateral anterior undercuts.
The patients will be divided equally into two groups(n=10), group (A) which will receive conventional heat cure acrylic denture, and group (B) which will receive 3D printed denture.
Methodology:
A primary impression will be taken for each patient and a special self-cured acrylic tray will be fabricated.
Zinc oxide secondary impression (caves outline, Cavex Holland)will be taken for each patient. The impression will be poured with extra hard stone and labeled master cast.
The cast will be scanned and saved in standard tessellation language (stl) format (master cats).
Jaw relation records for each patient will be taken in the conventional method. For group A: the setting up of teeth will be done in a conventional way on the articulator, and flasking of the waxed-up denture will be done. Wax elimination will be done then packing of heat cure acrylic will be done.
For group B: occlusion block will be scanned (swing scanner, DOF inc, Korea)(the scanner has an accuracy of 10 μm) after taking jaw relation record.
Virtual teeth form, size, and setting will be done on the CAD software (Exocad Dental CAD 3.0, Exocad GmbH, Germany) according to jaw relation record.
The denture base extension and thickness will be designed on CAD software. The teeth will be exported in a separate file and the denture base will be exported in a separate stl file.
The virtual denture stl files will be sent to the 3D printer software (Chitubox software, CBD-Tech, china) where slicing of the file and adjustment of layers setting will be done.
The virtual denture will be sent to the 3D printer (photon 3d printer, ANYCUBIC 3D Printing, china) to be printed (printer has Y axis resolution: 1.25um and Layer resolution: 25 ~ 100um), Teeth will be printed alone using tooth-colored resin(dental sand, Harz labs, Russia) and base will be printed alone using pink resin(dental pink, HArzz lab, Russia), then it will be ethyl alcohol washed (99% ethyl alcohol) to remove excess resin. The teeth will be placed in their places in the denture base and secured using pink resin.
Post-curing for remaining uncured resin will be done using a post-curing chamber for 30 minutes (bre-lux power unit 2,bredent, united kingdom).
Regarding the maxillary denture:
Retention will be measured clinically by using a force gauge (weihang electronic gauge,weihang industries, china) for group A and group B at 0,1 and 3 months. A force gauge will be applied by fixing the chain at the center of the polished surface of the denture. The pull end of the force gauge will be connected to the denture to measure the retention. The force gauge will pull the denture vertically downward until denture retention will be lost, and the denture will move vertically. The force at which the denture dislodges will be recorded in grams. The pull-off procedure will be repeated 10 times to obtain 10 records for each elder, and then the mean of these records will be calculated.
Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008) For group, A and group B denture base will be checked for accuracy of fit after scanning using a bench scanner with 1.3 megapixels dual camera and 10-micron accuracy (swing scanner, DOF inc, Korea) and will be compared to the virtual one planned on the master cast using metrology software (Geomagic Control X,3D systems, Canada). This will be done by the superimposition of the scanned printed or processed denture and the virtual reference denture. This will be done by selecting a point-to-point match and then the best fit function.
Color maps of the surface matching differences will be done. Areas that will be yellow to red in color will indicate impingement of the denture base with the cast. Areas that will be blue in color will indicate space between the denture base and cast. The ideal denture will show a color map that will be entirely green, giving a measurement value of 0, which will represent no processing deformation and an ideal adaptation of the denture base to the cast.
The results will be tabulated and statistically analyzed using SPSS Statistics Version 20 for Windows (SPSS, Inc., an IBM Company, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))group A will receive a conventional heat-cure acrylic denture |
| group B | Active comparator | Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))group B will receive a 3D printed complete denture |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with good neuromuscular control and free of systemic diseases
- the edentulous ridge was covered with healthy firm and dense mucosa
- They have upper and lower edentulous healthy alveolar ridges with no remaining roots, no severe bony undercut, or local pathological lesions.
- patients had no previous dentures with a nearly equal edentulous period.
Key exclusion criteria (3 listed)
- history of bad habits e.g. severe clenching.
- T.M.J disorders
- patients with xerostomia, high palatal vault, and short or hyperactive lips were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))retention for the two groups will be measured at 0,1 and 3months, patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software. | Device | group A, group B |
Primary outcome
accuracy of fit (adaptation)
Time frame: 1 week
the deviation of the denture fiitng surface from its corresponding cast will be measured using metrology software (GOM inspect,USA))
retention
Time frame: 3 months
retention will be measured using digital force gauge(weihang electronic gauge,weihang industries, china)
patient satisfaction
Time frame: 3 months
Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008)
1 secondary outcome
retention over time period
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 27112416Goodacre BJ, Goodacre CJ, Baba NZ, Kattadiyil MT. Comparison of denture base adaptation between CAD-CAM and conventional fabrication techniques. J Prosthet Dent. 2016 Aug;116(2):249-56. doi: 10.1016/j.prosdent.2016.02.017. Epub 2016 Apr 23.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) in people with Completely Edentulous Patients, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of fit (adaptation) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.